MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER; DQY, QJP

Catalog Number	BMK6F115
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis and has been evaluated.Evaluation of the returned benchmark revealed a fracture at the hub, underneath the strain relief.If the device is gripped by the hub and held at an angle during use, damage such as a kink may occur.This damage likely contributed to the reported leak during the procedure.Based on the reported event, the initial kink may have worsened to a subsequent fracture during attempts to remove the device.Further evaluation revealed bends and kinks along the catheter shaft.This damage was not mentioned in the reported complaint.Therefore, this damage is incidental to the complaint and the root cause could not be determined.Penumbra devices are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a medical procedure in the right middle meningeal artery (mma) using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician advanced the initial benchmark into the vessel and noticed that the benchmark was too short.The benchmark was removed and replaced with a longer benchmark.However, after placing the longer benchmark at the target location, the physician noticed a leak at the hub of the benchmark.The physician then attempted to remove the benchmark over a guidewire when the benchmark had fractured.It was reported that the benchmark was successfully removed over the guidewire.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 19388001
• Report Number: 3005168196-2024-00202
• Device Sequence Number: 6875927
• Product Code: DQY
• UDI-Device Identifier: 00815948025165
• UDI-Public: 815948025165
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2024
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2026
• Device Catalogue Number: BMK6F115
• Device Lot Number: F00006536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005